Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis
BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness o...
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Published in | Regional anesthesia and pain medicine Vol. 43; no. 1; pp. 84 - 91 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Copyright by American Society of Regional Anesthesia and Pain Medicine
01.01.2018
BMJ Publishing Group LTD Lippincott Williams & Wilkins |
Subjects | |
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Abstract | BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.
METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.
RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRSpain reduction 50% or greater74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.
CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003). |
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AbstractList | Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.
This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.
There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.
This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.
ClinicalTrials.gov (NCT02343003). Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.ClinicalTrials.gov (NCT02343003).CLINICAL TRIAL REGISTRATIONClinicalTrials.gov (NCT02343003). BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRSpain reduction 50% or greater74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003). Background and ObjectivesOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.MethodsThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.ResultsThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.ConclusionsThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003). |
Author | Lindley, David Soloman, Marc Kapural, Leonardo Loudermilk, Eric Desai, Mehul Davis, Tim Gupta, Anita DePalma, Michael Hunter, Corey Patel, Nilesh Choi, Daniel Buvanendran, Asokumar |
AuthorAffiliation | From the Orthopedic Pain Specialists, Santa Monica, CA; †Piedmont Comprehensive Pain Management Group, Greenville, SC; ‡Virginia iSpine Physicians, Richmond, VA; §Ainsworth Institute of Pain, New York, NY; ∥Interventional Pain Management of Texas, Mineral Wells, TX; Advanced Pain Management, Greenfield, WI; ††Valley Pain Consultants, Scottsdale; and ‡‡Valley Anesthesia Consultants, Phoenix, AZ; §§Department of Anesthesiology and Perioperative Medicine, Drexel University, Philadelphia, PA; ∥∥International Spine, Pain & Performance Center, Washington, DC; Department of Anesthesiology, Rush University Medical Center, Chicago, IL; and †††Center for Clinical Research, Winston Salem, NC |
AuthorAffiliation_xml | – name: From the Orthopedic Pain Specialists, Santa Monica, CA; †Piedmont Comprehensive Pain Management Group, Greenville, SC; ‡Virginia iSpine Physicians, Richmond, VA; §Ainsworth Institute of Pain, New York, NY; ∥Interventional Pain Management of Texas, Mineral Wells, TX; Advanced Pain Management, Greenfield, WI; ††Valley Pain Consultants, Scottsdale; and ‡‡Valley Anesthesia Consultants, Phoenix, AZ; §§Department of Anesthesiology and Perioperative Medicine, Drexel University, Philadelphia, PA; ∥∥International Spine, Pain & Performance Center, Washington, DC; Department of Anesthesiology, Rush University Medical Center, Chicago, IL; and †††Center for Clinical Research, Winston Salem, NC |
Author_xml | – sequence: 1 givenname: Tim surname: Davis fullname: Davis, Tim – sequence: 2 givenname: Eric surname: Loudermilk fullname: Loudermilk, Eric – sequence: 3 givenname: Michael surname: DePalma fullname: DePalma, Michael – sequence: 4 givenname: Corey surname: Hunter fullname: Hunter, Corey – sequence: 5 givenname: David surname: Lindley fullname: Lindley, David – sequence: 6 givenname: Nilesh surname: Patel fullname: Patel, Nilesh – sequence: 7 givenname: Daniel surname: Choi fullname: Choi, Daniel – sequence: 8 givenname: Marc surname: Soloman fullname: Soloman, Marc – sequence: 9 givenname: Anita surname: Gupta fullname: Gupta, Anita – sequence: 10 givenname: Mehul surname: Desai fullname: Desai, Mehul – sequence: 11 givenname: Asokumar surname: Buvanendran fullname: Buvanendran, Asokumar – sequence: 12 givenname: Leonardo surname: Kapural fullname: Kapural, Leonardo |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29095245$$D View this record in MEDLINE/PubMed |
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ContentType | Journal Article |
Copyright | Copyright © 2018 by American Society of Regional Anesthesia and Pain Medicine. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine.2017 Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine. 2017 Lippincott Williams & Wilkins |
Copyright_xml | – notice: Copyright © 2018 by American Society of Regional Anesthesia and Pain Medicine. – notice: Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine.2017 – notice: Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine. 2017 Lippincott Williams & Wilkins |
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PublicationTitle | Regional anesthesia and pain medicine |
PublicationTitleAlternate | Reg Anesth Pain Med |
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References | Farrar (R13-14-20171228) 2001; 94 Dawson (R15-14-20171228) 1998; 80 Ball (R12-14-20171228) 2014; 17 Arroll (R2-14-20171228) 2004; 328 Patel (R5-14-20171228) 2012; 13 Choi (R19-14-20171228) 2016; 29 Kamper (R16-14-20171228) 2010; 63 Desai (R7-14-20171228) 2016; 18 Choi (R8-14-20171228) 2011; 152 Ikeuchi (R9-14-20171228) 2011; 12 Franco (R4-14-20171228) 2015; 40 MacVicar (R20-14-20171228) 2013; 14 Dworkin (R14-14-20171228) 2008; 9 Hepper (R18-14-20171228) 2009; 17 Raunauld (R3-14-20171228) 2003; 48 Santana Pineda (R11-14-20171228) 2017; 42 Zhang (R1-14-20171228) 2010; 69 Smith (R17-14-20171228) 2003; 42 Kapural (R6-14-20171228) 2013; 14 |
References_xml | – volume: 80 start-page: 63 year: 1998 ident: R15-14-20171228 publication-title: J Bone Joint Surg Br doi: 10.1302/0301-620X.80B1.7859 – volume: 17 start-page: 638 year: 2009 ident: R18-14-20171228 publication-title: J Am Acad Orthop Surg doi: 10.5435/00124635-200910000-00006 – volume: 328 start-page: 869 year: 2004 ident: R2-14-20171228 publication-title: BMJ doi: 10.1136/bmj.38039.573970.7C – volume: 17 start-page: E175 year: 2014 ident: R12-14-20171228 publication-title: Pain Physician doi: 10.36076/ppj.2014/17/E175 – volume: 40 start-page: 363 year: 2015 ident: R4-14-20171228 publication-title: Reg Anesth Pain Med doi: 10.1097/AAP.0000000000000269 – volume: 42 start-page: 1477 year: 2003 ident: R17-14-20171228 publication-title: Rheumatology (Oxford doi: 10.1093/rheumatology/keg398 – volume: 12 start-page: 546 year: 2011 ident: R9-14-20171228 publication-title: Pain Med doi: 10.1111/j.1526-4637.2011.01086.x – volume: 18 start-page: 751 year: 2016 ident: R7-14-20171228 publication-title: Pain Med – volume: 14 start-page: 362 year: 2013 ident: R6-14-20171228 publication-title: Pain Med doi: 10.1111/pme.12023 – volume: 69 start-page: 483 year: 2010 ident: R1-14-20171228 publication-title: Ann Rheum Dis doi: 10.1136/ard.2009.113100 – volume: 152 start-page: 481 year: 2011 ident: R8-14-20171228 publication-title: Pain doi: 10.1016/j.pain.2010.09.029 – volume: 94 start-page: 149 year: 2001 ident: R13-14-20171228 publication-title: Pain doi: 10.1016/S0304-3959(01)00349-9 – volume: 9 start-page: 105 year: 2008 ident: R14-14-20171228 publication-title: J Pain doi: 10.1016/j.jpain.2007.09.005 – volume: 42 start-page: 62 year: 2017 ident: R11-14-20171228 publication-title: Reg Anesth Pain Med doi: 10.1097/AAP.0000000000000510 – volume: 14 start-page: 639 year: 2013 ident: R20-14-20171228 publication-title: Pain Med doi: 10.1111/pme.12000 – volume: 48 start-page: 370 year: 2003 ident: R3-14-20171228 publication-title: Arth Rheum doi: 10.1002/art.10777 – volume: 29 start-page: 3 year: 2016 ident: R19-14-20171228 publication-title: Korean J Pain doi: 10.3344/kjp.2016.29.1.3 – volume: 13 start-page: 383 year: 2012 ident: R5-14-20171228 publication-title: Pain Med doi: 10.1111/j.1526-4637.2012.01328.x – volume: 63 start-page: 760 year: 2010 ident: R16-14-20171228 publication-title: J Clin Epidemiol doi: 10.1016/j.jclinepi.2009.09.009 |
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Snippet | BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous... Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating... Background and ObjectivesOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous... |
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SubjectTerms | Ablation Adrenal Cortex Hormones - administration & dosage Adrenal Cortex Hormones - adverse effects Aged Analgesics - therapeutic use Arthralgia - diagnosis Arthralgia - etiology Arthralgia - physiopathology Arthralgia - therapy Arthritis Betamethasone - administration & dosage Betamethasone - adverse effects Catheter Ablation - adverse effects Chronic and Interventional Pain: Original Clinical trials Combined Modality Therapy Cross-Over Studies Denervation - adverse effects Denervation - methods Female Humans Immunomodulators Injection Injections, Intra-Articular Knee Knee Joint - drug effects Knee Joint - innervation Knee Joint - surgery Male Methylprednisolone - administration & dosage Methylprednisolone - adverse effects Methylprednisolone - analogs & derivatives Methylprednisolone Acetate Middle Aged Osteoarthritis Osteoarthritis, Knee - complications Osteoarthritis, Knee - diagnosis Osteoarthritis, Knee - physiopathology Osteoarthritis, Knee - therapy Pain Pain management Pain Measurement Prospective Studies Quality of life Regional anesthesia Time Factors Treatment Outcome Triamcinolone Acetonide - administration & dosage Triamcinolone Acetonide - adverse effects United States |
Title | Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis |
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